Working... Menu

Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006022
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 14, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery.

Condition or disease Intervention/treatment Phase
Kidney Cancer Melanoma (Skin) Biological: aldesleukin Drug: bryostatin 1 Phase 1

Detailed Description:


  • Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell proliferation in patients with melanoma or renal cell carcinoma.
  • Assess other intermediate markers of immune response in patients treated with this regimen.
  • Determine tumor responses, response durations, progression-free intervals, and survival of patients treated with this regimen.

OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three bryostatin 1 dose levels.

Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)
Study Start Date : September 2000
Actual Primary Completion Date : October 2003
Actual Study Completion Date : January 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell carcinoma

    • Unresectable disease
  • No known uncontrolled CNS metastases

    • CNS metastases allowed only if recently irradiated or known to be controlled



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Hemoglobin at least 8 g/dL
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Absolute lymphocyte count at least 1,000/mm^3


  • Total bilirubin no greater than 1.5 mg/dL OR
  • Conjugated bilirubin no greater than 0.3 mg/dL
  • AST no greater than 2.5 times upper limit of normal


  • Creatinine no greater than 2 mg/dL


  • No myocardial infarction within the past 6 months
  • No uncontrolled hypertension, angina, or congestive heart failure


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study
  • No known intolerance to acetaminophen
  • No primary or secondary immunodeficiency
  • No other condition that would preclude study


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • At least 1 month since prior topical, systemic, or inhaled corticosteroids
  • No concurrent topical, systemic, or inhaled corticosteroids


  • See Disease Characteristics


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006022

Layout table for location information
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: John D. Roberts, MD Massey Cancer Center

Layout table for additonal information
Responsible Party: Virginia Commonwealth University Identifier: NCT00006022     History of Changes
Other Study ID Numbers: CDR0000068034
P30CA016059 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Virginia Commonwealth University:
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Neoplasms
Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Bryostatin 1
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents